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Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children

NCT03667053 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-06-30

Study results available
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Summary

A phase 3, randomized, double-blind, placebo- and active-controlled, parallel-arm trial to assess the efficacy, safety, and pharmacokinetics of dasiglucagon relative to placebo and GlucaGen® when administered as a rescue therapy for severe hypoglycemia in children with type 1 diabetes mellitus (T1DM) treated with insulin

Conditions

Interventions

DRUG

dasiglucagon

glucagon analog

DRUG

placebo

placebo for dasiglucagon

DRUG

GlucaGen HypoKit

native glucagon

Sponsors & Collaborators

Principal Investigators

  • Christina M Sylvest, MSc Pharm · Zealand Pharma A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-28
Primary Completion
2019-06-28
Completion
2019-06-28
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Slovenia

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03667053 on ClinicalTrials.gov